BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 8413916 · Received March 12, 2019

    Report

    Report Number
    1526439-2019-51445
    Event Type
    Injury
    Date Received
    March 12, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING FILED AFTER REVIEW OF THE FOLLOWING LITERATURE ARTICLE: "EVALUATION OF SURGICAL STRATEGY OF CONVENTIONAL VS. PERCUTANEOUS ROBOT-ASSISTED SPINAL TRANS-PEDICULAR INSTRUMENTATION IN SPONDYLODISCITIS." NAUREEN KERIC, DAVID J. EUM, FEROZ AFGHANYAR, IZABELA RACHWAL-CZYZEWICZ, MIRJAM RENOVANZ, JENS CONRAD, DOMINIK M. A. WESP, SVEN R. KANTELHARDT, ALF GIESE. RECEIVED: 6 FEBRUARY 2016 / ACCEPTED: 26 APRIL 2016 / PUBLISHED ONLINE: 9 JUNE 2016. N=7, POST OP SCREW LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208249 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention